Device for release of a substance

ABSTRACT

A device for release of a solid substance into a flowing liquid during parenteral administration of the liquid to a patient includes a connector (1, with an inlet (6) and an outlet (12) for the liquid, and a valve assembly (4,5). The valve assembly has a valve core (5) which is rotatable between a bypass position and a working position. A releasable container (15), containing the solid substance, may be connected to the valve core (5). In the bypass position, liquid is conducted from the inlet to the outlet, by-passing the container (15). When the valve core (5) is moved to the working position, liquid is diverted into the container (15), for mixing with the solid substance, and then returned to the connector, where it then exits through the outlet (12).

This application is a continuation of application Ser. No. 297,245,filed on Feb. 14, 1989, now abandoned.

The present invention is related to a device intended to be used inparenteral liquid administration to a patient, whereby one during suchadministration desires to release a substance, such as a drug, to theliquid.

A device by which drugs can be supplied to a parenteral liquid flow isshown by EP-B-0059694. Modified such devices are shown by EP-A-0077604,EP 85850141.4, EP-A-0100296 and WO 86/03416. A device for connectioninto a flow of infusion liquid, where the liquid by means of a valve canbe led either via a vial for a drug to the patient or bypassing saidvial, is shown by EP-A-0163387. A similar device having three operativevalve positions, one for bypass of the liquid, one for dilution of adrug and one for emptying of a drug solution in an administrationsystem, is shown by U.S. Pat. No. 4,534,758. The two lastmentionedsystems require that a liquid preparation ready for administration isformed in the vial before the valve is put in an administrationposition.

An object of the present invention is to achieve a device where acontainer for a dry drug preparation exchangeably can be connected to aliquid administration system, whereupon the liquid can be deviated andbrought into contact with the drug thus that the drug is added to theliquid during administration of the liquid. A further object is toachieve a device where inadvertent deviation of the liquid is avoidedwhen no drug container is connected.

Thus the device of the invention is a device for release of a substancefrom a solid preparation thereof to a flowing liquid during simultaneousparenteral administration of the liquid to a patient, which devicecomprises a connector connectable into a system for parenteraladministration of the liquid, and having an inlet and outlet with avalve device which comprises a mobile valve core having a bypassposition providing for direct liquid flow from the inlet to the outletof the connector and a working position providing for liquid flow fromthe inlet of the connector into a releasable container for the solidpreparation. The device of an invention is characterized in that thevalve core has an outlet means and a separate inlet means simultaneouslyconnectable to an inlet means and a separate outlet means respectivelyon the releasable container, the releasable container further havingtherein means for conducting the liquid from the inlet thereof to aspace where it will contact the solid preparation, and further to theoutlet of the releasable container, and via the valve core in a flowpath to the outlet of the connector.

In a preferred embodiment of the invention the releasable container is amanoeuvre device for the valve core and the valve core has no othermanoeuvre devices. Thus, when the valve core is rotatable in the valvedevice the releasable container may function as a handle gripping theend of the valve core by means of its inlet and outlet means.Inadvertent deviation of the liquid when no container is connected willbe avoided by the invention in particular by this embodiment. Thus risksof liquid spillage and air suction into the administration system arereduced.

Preferably the outlet and inlet of the valve core are connectable to theinlet and outlet of the releasable container by socket means, andpreferably the socket means are tapered sockets fitting in taperedholes, and preferably the tapered sockets are the outlet means and inletmeans of the releasable container and that the tapered holes are theinlet means and outlet means on the valve core.

In a specially preferred embodiment of the device a filter is arrangedwithin the connector in the flow path from the valve in the workingposition to the outlet of the connector. Suitably the flow of liquid inthe bypass position of the valve has dual flow paths to the outleteither through the filter or via the valve core.

Use of a device as described for release of a substance from a solidpreparation thereof to a liquid during simultaneous parenteraladministration ministration of the liquid to a patient is a furtherembodiment of the invention.

The invention is further described with the reference to the encloseddrawings where

FIG. 1 shows a device according to the invention in a bypass position.

FIG. 2 shows the device in FIG. 1 in a working position.

FIG. 3 shows a connector in a bypass position,

FIG. 4 shows a connector in a bypass position in section along the lineIV--IV in FIG. 3,

FIG. 5 shows a section through a connector in a working position, with acontainer for a drug,

FIG. 6 shows an alternative rear portion of the connector in FIGS. 1-5.

With 1 is denoted a connector having an inlet via a transfer cannula 2in one end thereof, that will usually be the upper end in use, and anoutlet via a piercable membrane 3 in the opposite end thereof. In theconnector there is a valve device consisting of a cylindrical valvehousing 4 and a cylindrical valve core 5 turnable therein. Through thetransfer cannula 2 an inlet channel 6 runs, which in the bypass positionof the valve shown in FIG. 4 opens into a first bypass channel 7 throughthe valve core, said bypass channel opening into a first inner space 8in the connector. From the first inner space the liquid may, when thevalve is in the bypass position, follow either of dual flow paths via asecond bypass channel 9 through the valve core or via a bacteria filter10, sealingly attached along its periphery to walls defining a secondinner space 11 in the connector, to said second inner space which can beput in liquid connection with the outlet 12 of the connector via themembrane 3.

In the working position of the valve as shown in FIG. 5, which positionis at a 90° angle with the bypass position, the inlet channel 6 opensinto a channel 13 through the valve core, which channel via an outletmeans of the valve core being a tapered opening 13A is in communicationtherein with tapered inlet socket 14 on a releasable drug container 15being shaped substantially like an elongated box having its inlet socket14 and a separate tapered outlet socket 18 adjacent to each otherextending from one of the elongated faces thereof adjacent to one endthereof. Via an inlet channel 16 and a bed of granules 17 of thepharmaceutical preparation of the drug being released to the liquid, theliquid may circulate to the outlet socket 18 of the container, whichsocket via a tapered opening 19A in the valve core, being inlet meansthereof, is in communication with a channel 19 through the valve core.Said channel opens into the first inner space 8, while the channel 19has no opening directly into the second inner space 11, whereby theliquid at the working position of the valve can only pass via filter 10to space 11. The cylindrical surface of the valve core 5 seals againstthe cylindrical surface of the valve housing 4. The valve core issecured against axial movement by a flange 5A thereon resting against anedge 4A in the valve housing and by an axial extension 5B to the valvecore resting against a rear wall 21 of the connector 1. An airingchannel 20 is in a manner known per se arranged through the transfercannula 2. The first inner space 8 is limited by the rear portion 21 ofthe chamber and by side and end walls of the connector 1 and by thefilter 10. A second transfer cannula for connection of a drip chambervia the membrane 3 to the connector is hinted with 22. Alternatively adrip chamber function may be built into the connector 1 or located at adifferent position in the system.

An alternative rear portion 23 has a hydrophobic filter 24 through whichair from the downstream parts of the administration system can be letout.

While the device of the invention has a bypass position of the valvethereof and a working position in which the substance is released andadministered it does not have a position in which the substance ismerely reconstituted or dissolved while remaining in the releasablecontainer.

The parenteral administration system may further comprise known detailssuch as a liquid container (bottle or gag), conduits, injection ports,branchings, clasps, pumps, a cannula etc.

The device may be made as molded plastic parts, preferably in disposabledesign.

We claim:
 1. A device for release of a solid preparation into a flowingliquid during simultaneous parenteral administration of the liquid to apatient, the device comprising a connector having:an inlet and an outletconnectable into a system for parental administration of a liquid; and avalve means in fluid communication with the inlet; wherein the valvemeans includes a valve housing, a valve core rotatable in the valvehousing between a bypass position and a working position; wherein thevalve core has an outer coupling surface containing an external outletport and an external inlet port spaced from the outlet port forconnection to a releasable container; wherein the valve means furtherincludes first passage means for directing fluids from the connectorinlet to the connector outlet when the valve core is in the bypassposition; and wherein the valve means includes second passage means fordirecting fluids from the connector inlet to the external outlet port,and third passage means for directing fluids from the external inletport to the connector outlet, when the valve core is in the workingposition, wherein the connector includes first and second flow pathsbetween the valve core and the connector outlet; wherein the first flowpath is essentially unrestricted; wherein the second flow path includesa filter means; wherein the first passage means communicates with thefirst flow path when the valve core is in the bypass position; andwherein the third passage means communicates only with the second flowpath when the valve core is in the working position.
 2. A deviceaccording to claim 1, wherein the valve core includes a rotational axis,and the ports extend parallel to the rotational axis and are disposed onopposite sides thereof.
 3. A device for release of a solid preparationinto a flowing liquid during simultaneous parenteral administration ofthe liquid to a patient, comprising a connector and a releasablecontainer, wherein the connector comprises:an inlet and an outletconnectable into a system for parental administration of a liquid; and avalve means in fluid communication with the inlet; wherein the valvemeans includes a valve core moveable between a bypass position and aworking position; wherein the valve core has an external outlet port andan external inlet port spaced from the outlet port for connection to areleasable container; wherein the valve means includes first passagemeans for directing fluids from the connector inlet to the connectoroutlet when the valve core is in the bypass position; and wherein thevalve means includes second passage means for directing fluids from theconnector inlet to the external outlet port, and third passage means fordirecting fluids from the external inlet port to the connector outlet,when the valve core is in the working position; and wherein thereleasable container includes a space for containing a solidpreparation, a container inlet and a separate container outlet; meansfor releasably coupling the container inlet and outlet to the valve coreoutlet port and valve core inlet port, respectively; and containerpassage means for directing fluid from the container inlet to flow intothe space and to exit the space at a distance therefrom to the containeroutlet.
 4. A device according to claim 3, wherein the releasablecontainer is a maneuverable device for the valve core and that the valvecore has no other maneuverable devices.
 5. A device according to claim4, wherein the means for coupling the container and valve core comprisesocket means.
 6. A device according to claim 5, wherein the socket meanscomprise tapered holes and tapered sockets fitting therein.
 7. A deviceaccording to claim 6, wherein the tapered sockets are disposed on thereleasable container and that the tapered holes are provided in thevalve core.
 8. A device according to claim 3, wherein the containerpassage means is arranged such that liquid enters and exits the spacesubstantially at opposite ends thereof.
 9. A device according to claim3, wherein the connector includes first and second flow paths betweenthe valve core and the connector outlet; where in the first flow path isessentially unrestricted; wherein the second flow path includes a filtermeans; wherein the first passage means communicates with the second flowpath when the valve core is in the bypass position; and wherein thethird passage means communicates only with the second flow path when thevalve core is in the working position.
 10. A method of dispensing asolid preparation comprising the steps of:(a) providing a connectorhaving an inlet, an outlet, and valve means in fluid communication withthe inlet; wherein the valve means includes a valve core moveablebetween a bypass position and a working position; wherein the valve corehas an external outlet port and an external inlet port spaced from theoutlet port for connection to a releasable container; wherein the valvemeans includes first passage means for directing fluids from theconnector inlet to the connector outlet when the valve core is in thebypass position; and wherein the valve means includes second passagemeans for directing fluids from the connector inlet to the externaloutlet port, and third passage means for directing fluids from theexternal inlet port to the connector outlet, when the valve core is inthe working position; (b) positioning the valve core into the bypassposition; (c) connecting the inlet and outlet into a parentaladministration tube containing a liquid so that liquid flows through theconnector; (d) providing a releasable container which includes a spacefor containing a solid preparation, a container inlet and a separatecontainer outlet; means for releasable coupling the container inlet andoutlet to the valve core outlet port and valve core inlet port,respectively; and passage means for directing fluid from the containerinlet to flow into the space and to exit the space as a distancetherefrom to the container outlet; (e) coupling the releasable containerto the connector; and (f) moving the valve core from the bypass positionto the working position such that the liquid in the parentaladministration tube is diverted through the space containing thepreparation thereby dispensing the same.